The progression of medical science, various environmental considerations, and healthy lifestyle choices have resulted in dramatic increases in life expectancies in many developed and even underdeveloped countries. With extended life durations, more and more people, even “healthy” adults and/or children, can be subject to intermittent or extended periods of fecal incontinence or other infirmities which render the ability to use a restroom or even a bedpan extremely difficult if not impossible. As is readily understood, exposure to fecal matter, for any duration, can be detrimental to tissue health such as maceration or ulcers, patient comfort, and general environment cleanliness and sanitation.
Commonly, persons suffering from fecal incontinence have some degree of mobility but may have a degree of mobility that inhibits expedient if any use of restroom facilities if suffering from fecal incontinence. Users with limited mobility commonly require the assistance of caregivers or the like associated with assisting with the user to restrooms or tending to the user so as to limit the exposure or duration of exposure of the user to fecal excrement. Due to the availability of such caregivers and/or the desired privacy of users with no appreciable mental infirmities, some users may attempt unassisted use of restroom facilities which could expose the user to risk of injury or exacerbate an underlying infirmity.
Various fecal matter containment appliances are commonly ill-suited for use with the area of the user proximate the anal opening. The contours of the anal cleft and the pressures associated with a prone patient position generally result in other appliances, such as ostomy appliances or the like, as being ill suited for use with cooperation of the anal cleft. Further, the lack of any ancillary structure permanently or temporality affixed to the anatomy of the user renders use of such appliance as being associated with the anus impractical if not ill advised. Commonly, the containment device cooperates with an ostometric appliance rather than the tissue of the patient so as to maintain isolation between the containment device and the tissue. Commonly, the openings associated with use of such devices directly cooperate with the stoma appliance so as to maintain the integrity and condition of the tissue surrounding the anatomic device and have generally rigid constructions so as to facilitate a secure interface therewith. Such appliances are also commonly associated with the abdominal wall to facilitate the convenience of the user with interaction with the appliance. The anatomic location as well as the contour of the anatomy surrounding the anus renders such appliances ill-suited for cooperation with the area proximate the anus. Understandably, not all fecal incontinences support the intrusive and excessive alteration of the anatomy of the user associated with ostometric appliances. Known anal fecal matter collecting appliances, sometimes referred to as fecal bags, suffer from various drawbacks.
In addition to the considerations associated with user comfort referred to above, another aspect of fecal containment appliances is associated with maintaining the integrity of the tissue surrounding the anus. Repeated removal and replacement of a fecal bag can, result in injury to the tissue or other complications associated with extended periods of placement of the fecal containment appliance. Aggressive adhesives or adhesives having a high tack adhesion parameter can damage the tissue during removal of the appliance. Improper initial placement of the adhesive can result in replacement of the adhesive during each replacement of the appliance which only exacerbates the undesirable affects associated with repeated placement and removal of the adhesive. Unfortunately, less aggressive adhesives can result in configurations wherein the containment appliance comes loose or mores relative to the anus during use of the same. Partial engagement of the engagement interface can result in leakage from the appliance and exacerbate the considerations associated with user tissue care as excrement may be held in contact with surrounding tissue for extended durations and/or may soil undergarments and/or bedding.
Although adhesives having lower tack adhesion parameters mitigate some of the complications associated with protecting the tissue surrounding the anus, lowering the tack adhesion can exacerbate leakage and/or movement of the appliance during use. Such considerations can be particularly problematic for bedridden users as a majority of the weight of the user is born upon the hip area, and the appliance disposed between the user and the supporting surface, during rolling or shifting activities. Accordingly the contact interface of the appliance must be supple enough to accommodate cooperation with the contour of the anal cleft yet robust enough to maintain a desired engagement with user tissue surrounding the anus.
Another consideration associated with the use of such appliances is the ability of the appliance to adequately cooperate with the perineal area of the user. Inadequate cooperation of the appliance with the perineum can result in exposure of the urinary anatomy, such as the testes, penis, vagina, catheters or the like, to fecal matter. Exposure of such anatomy or medical appliances results in unsanitary conditions that tend to increase the incidence of bladder and/or urinary tract infections. Desired placement and maintained engagement of the area of the appliance that faces the forward positioned anatomy lessens the potential of such consequences but the close proximity and overlapping shape of the anatomy associated with the perineal area, particularly for prone users, complicates the ability to maintain a desired cooperation of the appliance with the user.
Still another consideration to the consideration of such appliances is in the construction of the container and the ability of the container to obtain a generally flat shape wherein opposite sides of the container overlay one another but are movable so as to not unduly interfere with the passage of fecal matter into the container. Some such appliances are so rigid and constructed such that portions of the appliance overlap the opening associated with the anus. The overlapping of the opening of the appliance with portions of the container tends to overstress the generally sealed interaction of the appliance with the anal area of the wearer resulting in leakage or displacement of the container relative to the anatomy of the wearer and can result in failure of the appliance to adequately capture the fecal matter in a sanitary manner.
Many such appliances also fail to provide an adequate methodology for providing a sealed configuration of fecal matter containing used appliances. Leaving an infirm user unattended for extended periods can result in the collection of an excessive volume of fecal matter rendering a closure methodology inoperable. Many such prior art appliances include supplemental containers associated configured to receive used appliances. Such methodologies increase the time and costs associated with servicing and maintaining such appliances.
Therefore, there is a need for anal fecal matter appliance that can be quickly and efficiently associated with the anus of a user; is constructed and cooperates with the user to provide a substantially circumferential interaction with the tissue of the user proximate the anus, including the perineal area; is not uncomfortable to use; and is constructed to cooperate with the anal cleft in a manner that does not interfere with passage of fecal matter into the appliance.